Significance and Use 4.1 This practice provides: 4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal. 4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing. 4.1.3 Information on the main challenges faced when testing SUSs for integrity. 4.2 This practice can be used by SUS suppliers and SUS end users to define an integrity assurance strategy for SUSs, with the relevant tests when appropriate.Scope 1.1 This practice uses quality risk management (QRM) and life-cycle approach to establish integrity assurance of single-use systems (SUSs), such as but not limited to bag assemblies and liquid transfer sets for processing, storage, and shipping of (bio)pharmaceutical products. It gives recommendations to identify failure modes and risks associated with such systems and their use-cases and how to identify the relevant leak(s) of concern. Integrity assurance in this context is limited to the barrier properties of the SUS, linked to microbial integrity and bioburden control (product quality) and liquid product loss (operator and environmental contamination). The required level of integrity assurance will depend on how critical the application is and can be interpreted in different ways. Other package barrier properties different from that, such as but not limited to gas barrier properties for gas headspace preservation, are not considered. 1.2 The test method overview provides descriptions that focus on the standard test setup and the identification of challenges in combination with SUSs. Details, including specific test setups, test parameter, and result interpretation, are not discussed. 1.3 This practice is not intended to apply to the use of single-use technology for primary containers, combination products (products composed of any combination of a drug, device, or biological product), or devices. Appropriate procedures related to these products are discussed in documents covering the integrity assurance for primary containers (1)2 or medical products (2, 3). 1.4 Techniques and procedures for complaint management and root cause analysis related to integrity failures are also not discussed. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1375 - Demolition Materials (549)
1377 - Cartridge and Propellant Actuated Devices and Components (524)
4720 - Hose and Flexible Tubing (552)
4730 - Hose, Pipe, Tube, Lubrication, and Railing Fittings (1823)
5120 - Hand Tools, Nonedged, Nonpowered (1124)
5305 - Screws (781)
5306 - Bolts (996)
5310 - Nuts and Washers (864)
5330 - Packing and Gasket Materials (583)
5340 - Hardware, Commercial (953)
5905 - Resistor (753)
5910 - Capacitors (783)
5930 - Switches (1012)
5935 - Connectors, Electrical (4357)
5940 - Lugs, Terminals, and Terminal Strips (564)
5945 - Relays and Solenoids (733)
5950 - Coils and Transformers (856)
5960 - Electron Tubes and Associated Hardware (1630)
5961 - Semiconductor Devices and Associated Hardware (707)
6145 - Wire and Cable, Electrical (1629)
6240 - Electric Lamps (662)
6505 - Drugs and Biologicals (1343)
6515 - Medical and Surgical Instruments, Equipment, and Supplies (1907)
6520 - Dental Instruments, Equipment, and Supplies (790)
6530 - Hospital Furniture, Equipment, Utensils, and Supplies (745)
6610 - Flight Instruments (540)
6625 - Electrical and Electronic Properties Measuring and Testing Instruments (1241)
6640 - Laboratory Equipment and Supplies (1187)
6810 - Chemicals (1114)
8010 - Paints, Dopes, Varnishes, and Related Products (2046)
8030 - Preservative and Sealing Compounds (554)
8140 - Ammunition and Nuclear Ordnance Boxes, Packages and Special Containers (797)
8305 - Textile Fabrics (910)
8415 - Clothing, Special Purpose (660)
8455 - Badges and Insignia (3093)
8915 - Fruits and Vegetables (531)
9330 - Plastics Fabricated Materials (759)
FACR (1647)
ISDA (1776)
ISDD (786)
ISDF (1827)
ISDN (581)
MISC (1045)
PACK (539)
SESS (581)
Aerospace Material (225)
Aircraft Air Conditioning, Heating, and Pressurizing Equipment (334)
Aircraft Hydraulic, Vacuum, and De-icing System Components (263)
Ammunition, 75mm through 125mm (192)
Ammunition, over 30mm up to 75mm (208)
Ammunition, through 30mm (349)
Analytical Chemistry (180)
Bombs (192)
Building (414)
Bulk Explosives (261)
Cartridge and Propellant Actuated Devices and Components (524)
Consumer Product Evaluation (267)
Copper (192)
Demolition Materials (549)
Electrical and Magnetic Conductor (162)
Electronics (153)
Environmental Toxicology (187)
Fire Control Computing Sights and Devices (338)
Fire Control Radar Equipment, except Airborne (197)
Fuzes and Primers (454)
Geotechnical Engineering (217)
GUN (640)
Land Mines (276)
Medical Device and Implant (427)
Military Chemical Agents (156)
Miscellaneous Aircraft Accessories and Components (231)
Miscellaneous Fire Control Equipment (216)
Nondestructive Testing (246)
Nonferrous Metal and Nonferrous Alloy (367)
Nuclear Technology (274)
Optical Sighting and Ranging Equipment (451)
Paint and Related Coating (456)
Parachutes; Aerial Pick Up, Delivery, Recovery Systems; and Cargo Tie Down Equipment (324)
Petroleum (378)
Plastic Pipe (248)
Pyrotechnics (175)
Road and Paving (177)
Rockets, Rocket Ammunition and Rocket Components (368)
Rubber (166)
Security System Pedestrian and Walkway Safety (157)
Specialized Test and Handling Equipment, Nuclear Ordnance (150)
Sports and Recreation (316)
Steel (908)
Torpedos and Components, Inert (258)
銃 (621)